July 2023 FDA Recall Fingolimod by Ascend Laboratories, Llc
D-0925-2023 - Failed Dissolution Specifications
This Class II drug recall was voluntarily initiated by Ascend Laboratories, Llc on July 11, 2023 for the product Fingolimod. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0925-2023
Failed Dissolution Specifications
07-11-2023
07-26-2023
2652 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Ascend Laboratories, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-476-30.
Batch or Lot Expiration Information
Lot# Lot 22122841, Exp August 2025
